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PainChek Nears FDA Approval, Hits 100,000 Licences with Infant App Launch
6:36pm on Sunday 1st of June, 2025 AEST
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Healthcare
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PainChek Nears FDA Approval, Hits 100,000 Licences with Infant App Launch
6:36pm on Sunday 1st of June, 2025 AEST
Key Points
US FDA De Novo submission confirmed complete; decision expected by May 2025
100,000 global contracted licences with $4.8M ARR, up 22% year-on-year
68,458 licences implemented, reflecting 18% annual and 11% quarterly growth
Successful Infant App Early Access Program and upcoming consumer launch
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